CLINUVEL Pharmaceuticals Limited (ASX:CUV) Reports Preliminary CUV052 Study Results
Study Completion and Safety Profile
CLINUVEL Pharmaceuticals Limited (ASX:CUV) announced the completion of its CUV052 study, evaluating SCENESSE® in adolescent erythropoietic protoporphyria (EPP) patients. The preliminary results indicate a consistent safety profile between adult and adolescent patients, with SCENESSE® well tolerated across all participants.
Pharmacological Findings
Biochemical analyses revealed that the controlled-release profile of the SCENESSE® implant in adolescents was similar to previous adult studies. Although active drug levels were higher in adolescents, they remained within historical ranges observed in healthy adult volunteers.
Regulatory Pathway and Future Steps
Pending final data analysis, scheduled for the second half of 2025, the findings from CUV052 will support CLINUVEL’s submission to regulatory agencies for expanding SCENESSE®’s indication to include adolescents. The company plans to incorporate the study data to seek label expansions in jurisdictions where SCENESSE® is approved.
Executive Comments
“Over the last three years, we have diligently collected and analysed data which support a positive risk-benefit profile of SCENESSE® in adolescent EPP patients, following demand from patients and physicians to broaden access to treatment,” said Dr Dennis Wright, Chief Scientific Officer of CLINUVEL.
“As one could expect from our longer-term use, initial data from the CUV052 study demonstrate that the drug is well tolerated, consistent with that seen under conditions of use in adults. Adolescents seem to have slightly higher drug exposure in this study but these results are consistent with historical ranges in earlier adult studies. We understand from regulatory decision makers that pharmacology data can be used to support label expansion. It is hoped that the complete analyses of data from CUV052, now underway, will ultimately address regulatory hesitance and allow wider adolescent use.”
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